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Short Messaging Service Program to Help Quit Smoking During Perioperative Period. (SMS2QUIT)

Primary Purpose

Tobacco Use Cessation, Perioperative/Postoperative Complications, Tobacco Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief behavioral intervention
SMS Program
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Use Cessation focused on measuring Tobacco, Cigarettes, Surgery, Text Message, SMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment
  • Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and;
  • Owning a device with access to SMS with an unlimited text plan

Exclusion Criteria:

  • Surgery on the day of POE evaluation
  • Any active psychiatric condition

Sites / Locations

  • Mayo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"Quit for a bit"

"Quit for good"

Arm Description

Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program.

Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program.

Outcomes

Primary Outcome Measures

Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.
The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects
Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service

Secondary Outcome Measures

Full Information

First Posted
February 5, 2019
Last Updated
July 8, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03839043
Brief Title
Short Messaging Service Program to Help Quit Smoking During Perioperative Period.
Acronym
SMS2QUIT
Official Title
Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.
Detailed Description
The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery ("quit for a bit") can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence ("quit for good").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Perioperative/Postoperative Complications, Tobacco Smoking
Keywords
Tobacco, Cigarettes, Surgery, Text Message, SMS

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two hypotheses will be tested using a randomized controlled trial of 200 cigarette smokers scheduled for elective surgery that are willing to maintain temporary abstinence from cigarettes. Using a validated decision aid, subjects stratify according to intended duration of abstinence and randomize within each stratum to receive either a "quit for a bit" or a "quit for good" intervention. Both stratums employ a Short Message Service (SMS or "text") to deliver extended follow-up and assess engagement, e.g. subject response to text requests (ex. # of cigarettes smoked). The "quit for a bit" intervention targets abstinence in the first 7 days after surgery, and has an option of receiving continued messages. Both interventions can continue messages beyond day 30. We will assess treatment engagement outcomes and the continuation rate. We will also obtain biochemically-confirmed abstinence data on the morning of surgery and 30 days post-surgery, as well as self-reported abstinence.
Masking
Participant
Masking Description
A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Quit for a bit"
Arm Type
Experimental
Arm Description
Brief behavioral intervention (~5 min) that focus on quitting smoking from the morning of surgery until one week after surgery + "Quit for a bit" SMS program.
Arm Title
"Quit for good"
Arm Type
Active Comparator
Arm Description
Brief behavioral intervention (~5 min) that focus on quitting smoking permanently for as long as possible +" Quit for good" SMS program.
Intervention Type
Behavioral
Intervention Name(s)
Brief behavioral intervention
Intervention Description
"Quit for a bit"- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. "Quit for good"- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure.
Intervention Type
Other
Intervention Name(s)
SMS Program
Intervention Description
"Quit for a bit"- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days."Quit for good"- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes.
Primary Outcome Measure Information:
Title
Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30
Description
Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.
Time Frame
30 days Post Op
Title
The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects
Description
Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service
Time Frame
Cumulative from Day 1 to Day 30 Post Op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and; Owning a device with access to SMS with an unlimited text plan Exclusion Criteria: Surgery on the day of POE evaluation Any active psychiatric condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Warner, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Short Messaging Service Program to Help Quit Smoking During Perioperative Period.

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